Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
One randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). But, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%)
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Gyeonggi-do
-
Goyang, Gyeonggi-do, Corée, République de, 410-769
- National Cancer Center Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients have laparoscopic colorectal surgery for cancer at National Cancer Center
- Patients should sign a written informed consent
- Age between 18-80 years
- Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- Adequate kidney function Creatinine ≤ 1.5 mg/dl
- No remarkable evidence of heart dysfunction and lung dysfunction
Exclusion Criteria:
- Patients undergo emergency surgery with multiple symptoms
- Open colorectal surgery for cancer or conversion to an open procedure
- Patients who undergo only ostomy surgery
- Palliative surgery
- Surgery combined with other organs
- Patients on treatment with recurred cancer
- Patients who have active bacterial infection and required parenteral antibiotics
- Patients have an allergy to Cefoxitin
- Other organ cancer history(except who had radical excision for skin cancer)
- Presence of other serious disease
- Mentally ill patients
- Legally unable to participate in clinical trial
- Lactating or pregnant women
- Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
- Not eligible to participate for other reasons by doctor's decision
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: One dose
One dose prophylactic antibiotic
|
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Surgical site infection
Délai: Three weeks after surgery
|
any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
|
Three weeks after surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall infection
Délai: Three weeks after surgery
|
Overall infection including surgical site infection, pneumonia, urinary tract infection etc.
|
Three weeks after surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jae Hwan Oh, Center for Colorectal Cancer, National Cancer Center Korea
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCCCTS-10-485
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